Extracorporeal CirculationPhase 3OPTIMUS-PRIMENCT02906514
Priming of Cardiopulmonary Bypass With Hydroxyethyl Starch 130/0.4 or Sodium Chloride 0.9% : Pilot Study in Adult Elective Conventional Cardiac Surgery
A Phase 3 study testing Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius) and Sodium Chloride 0.9% (Fresenius) in people with Extracorporeal Circulation and Cardiac Surgery, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Best priming for cardiopulmonary bypass in cardiac surgery is unknown. Efficacy and toxicity of Hydroxyethyl Starch 130/0.4 used in this context are uncertain. The aim of this pilot study is to determine if Hydroxyethyl Starch 130/0.4 is more effective than Sodium Chloride 0.9% in short term hemodynamic purpose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Extracorporeal Circulation, Cardiac Surgery
- What is being tested?
- Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius) and Sodium Chloride 0.9% (Fresenius)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 6 Dec 2016to Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective conventional cardiac surgery with cardiopulmonary bypass
- Patients insured under the French social security system
Who cannot join
- Pregnancy
- Patients placed under guardianship
- Urgent surgery
- Cardiac surgery without cardiopulmonary bypass
- Anterior cardiac surgery
- Non conventional cardiac surgery (mini-invasive surgery, dual valve replacement, right heart surgery)
Show all 13Show fewer
- Simultaneous inclusion in another study with potential interference in outcomes
- Heparin-induced thrombocytopenia
- Chronic renal insufficiency (glomerular filtration rate < 60mL.min-1.m-2)
- Nature/nurture hemostasis disorders, in particular Von Willebrand disease and hemophilia
- Hydroxyethyl Starch allergy
- Weight under 33 kg
- Mechanical hemodynamic support at the end of the surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Priming of Cardiopulmonary Bypass With Hydroxyethyl Starch 130/0.4 or Sodium Chloride 0.9% : a Double Blind Randomized Pilot Study in Adult Elective Conventional Cardiac Surgery
Best priming for cardiopulmonary bypass in cardiac surgery is unknown. Efficacy and toxicity of Hydroxyethyl Starch 130/0.4 used in this context are uncertain.
The aim of this pilot study is to determine if Hydroxyethyl Starch 130/0.4 is more effective than Sodium Chloride 0.9% in short term hemodynamic purpose without side renal or hemostatic effect.
- Conditions
- Extracorporeal Circulation, Cardiac Surgery
- Being tested
- Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius), Sodium Chloride 0.9% (Fresenius)
- Keywords
- Hydroxyethyl Starch, Cardiac surgery, Priming of cardiopulmonary bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)Drug
1000mL used for cardiopulmonary bypass priming
Sodium Chloride 0.9% (Fresenius)Drug
1000mL used for cardiopulmonary bypass priming
| Study group | Role | What they receive |
|---|---|---|
| Hydroxyethyl starch 130/0.4 | Experimental | Not described Receives: Drug: Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius) |
| Sodium Chloride 0.9% | Placebo comparator | Not described Receives: Drug: Sodium Chloride 0.9% (Fresenius) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Supplementary volume of fluid administered during cardiopulmonary bypass (ml)
Fluid administered during cardiopulmonary bypass for normal functioning, with the exception of blood product, cardioplegia and priming
Measured: Day 1 (From initiation to separation of cardiopulmonary bypass)
Secondary outcomes (39)
Variation of preoperative hematocrit and lowest hematocrit during cardiopulmonary bypass
Continuous monitoring of hematocrit during cardiopulmonary bypass.
Measured: Day 1 (From initiation to separation of cardiopulmonary bypass)
Fluid balance
Difference between total intraoperative volume of fluids administered (vascular filling, blood products, cardioplegia, priming) and total intraoperative volume of fluids loss (urine, bleedings)
Measured: Hour 0
Fluid balance
Difference between total intraoperative volume of fluids administered (vascular filling, blood products, cardioplegia, priming) and total intraoperative volume of fluids loss (urine, bleedings)
Measured: Hour 12
Sequential Organ Failure Assessment score
Measured: Hour 24
Sequential Organ Failure Assessment score
Measured: Hour 0
Acid-Base parameters : arterial pH
Measured: Hour 24
Acid-Base parameters : Base Excess
Measured: Hour 0
Acid-Base parameters : Base Excess
Measured: H24
Acid-Base parameters : Lactatemia
Measured: Hour 0
Acid-Base parameters : Lactatemia
Measured: Hour 24
Acid-Base parameters : Chloremia
Measured: Hour 0
Acid-Base parameters : Chloremia
Measured: Hour 24
Coagulation parameters : platelets
Measured: Hour 0
Coagulation parameters : prothrombin
Measured: Hour 0
Coagulation parameters : activated partial thromboplastin
Measured: Hour 0
Coagulation parameters : fibrinogen level
Measured: Hour 0
Coagulation parameters : platelets
Measured: H24
Coagulation parameters : prothrombin
Measured: H24
Coagulation parameters : activated partial thromboplastin
Measured: H24
Coagulation parameters : fibrinogen level
Measured: H24
Hemoglobin level
Measured: Hour 0
Hemoglobin level
Measured: Hour 24
Surgical bleeding
Measured: Hour 12
Surgical bleeding
Measured: during surgical drainage, an average of 24 hours
Revision surgery for bleeding
Measured: Hour 12
Delay for ablation of surgical drainage
Measured: Day of ablation of surgical drainage, 24 hours
Antiemetic medication use
Any antiemetic medication used during this period
Measured: end of intensive care unit stay, 24 hours
Delay to first extubation (number of hours)
Measured: Hour of first extubation, an average of 5 hours
Intensive care unit stay (number oh days)
Measured: Day of intensive care unit stay exit
Hospital stay (number of days)
Measured: Day of hospital exit, an average of 7 days
Creatinine level variation
Measured: Day 5
Creatinine level variation
Measured: Day 28
Creatinine level variation
Measured: Day 90
Renal replacement therapy use during intensive care stay
Measured: end of intensive care unit stay, an average of 24 hours
Renal replacement therapy dependency
Measured: Day 28
Renal replacement therapy dependency
Measured: Day 90
Mortality of any cause
Measured: During hospital stay, an average of 7 days
Mortality of any cause
Measured: Day 28
Mortality of any cause
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start6 Dec 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extracorporeal CirculationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906514
- Sponsor's protocol ID
- 69HCL15_0235
- Acronym
- OPTIMUS-PRIME
- Status last verified
- Feb 2018
- First submitted
- 29 Aug 2016
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schweizer R, Lameche M, Coelembier C, Portran P, Fornier W, Colombet B, Grinberg D, Pozzi M, Jacquet-Lagreze M, Fellahi JL. Cardiopulmonary Bypass Priming with Hydroxyethyl Starch 6% 130/0.4 or Sodium Chloride 0.9%: A Preliminary Double-Blind Randomized Controlled Study in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Dec;33(12):3534-3535. doi: 10.1053/j.jvca.2019.05.003. Epub 2019 May 10. No abstract available.
PubMed 31138465
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Priming of Cardiopulmonary Bypass With Hydroxyethyl Starch 130/0.4 or Sodium Chloride 0.9% : a Double Blind Randomized Pilot Study in Adult Elective Conventional Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02906514
- Acronym / sponsor ID
- OPTIMUS-PRIME / 69HCL15_0235
- Conditions
- Extracorporeal Circulation, Cardiac Surgery
- Keywords
- Hydroxyethyl Starch, Cardiac surgery, Priming of cardiopulmonary bypass
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Dec 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Best priming for cardiopulmonary bypass in cardiac surgery is unknown. Efficacy and toxicity of Hydroxyethyl Starch 130/0.4 used in this context are uncertain.
The aim of this pilot study is to determine if Hydroxyethyl Starch 130/0.4 is more effective than Sodium Chloride 0.9% in short term hemodynamic purpose without side renal or hemostatic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxyethyl starch 130/0.4 | Experimental | Drug: Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius) |
| Sodium Chloride 0.9% | Placebo comparator | Drug: Sodium Chloride 0.9% (Fresenius) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective conventional cardiac surgery with cardiopulmonary bypass
- Patients insured under the French social security system
Key exclusion criteria (13 listed)
- Pregnancy
- Patients placed under guardianship
- Urgent surgery
- Cardiac surgery without cardiopulmonary bypass
- Anterior cardiac surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)1000mL used for cardiopulmonary bypass priming | Drug | Hydroxyethyl starch 130/0.4 |
| Sodium Chloride 0.9% (Fresenius)1000mL used for cardiopulmonary bypass priming | Drug | Sodium Chloride 0.9% |
Primary outcome
Supplementary volume of fluid administered during cardiopulmonary bypass (ml)
Time frame: Day 1 (From initiation to separation of cardiopulmonary bypass)
Fluid administered during cardiopulmonary bypass for normal functioning, with the exception of blood product, cardioplegia and priming
39 secondary outcomes
Variation of preoperative hematocrit and lowest hematocrit during cardiopulmonary bypass
Time frame: Day 1 (From initiation to separation of cardiopulmonary bypass)
Fluid balance
Time frame: Hour 0
Fluid balance
Time frame: Hour 12
Sequential Organ Failure Assessment score
Time frame: Hour 24
Sequential Organ Failure Assessment score
Time frame: Hour 0
Acid-Base parameters : arterial pH
Time frame: Hour 24
Acid-Base parameters : Base Excess
Time frame: Hour 0
Acid-Base parameters : Base Excess
Time frame: H24
Acid-Base parameters : Lactatemia
Time frame: Hour 0
Acid-Base parameters : Lactatemia
Time frame: Hour 24
Acid-Base parameters : Chloremia
Time frame: Hour 0
Acid-Base parameters : Chloremia
Time frame: Hour 24
Coagulation parameters : platelets
Time frame: Hour 0
Coagulation parameters : prothrombin
Time frame: Hour 0
Coagulation parameters : activated partial thromboplastin
Time frame: Hour 0
Coagulation parameters : fibrinogen level
Time frame: Hour 0
Coagulation parameters : platelets
Time frame: H24
Coagulation parameters : prothrombin
Time frame: H24
Coagulation parameters : activated partial thromboplastin
Time frame: H24
Coagulation parameters : fibrinogen level
Time frame: H24
Hemoglobin level
Time frame: Hour 0
Hemoglobin level
Time frame: Hour 24
Surgical bleeding
Time frame: Hour 12
Surgical bleeding
Time frame: during surgical drainage, an average of 24 hours
Revision surgery for bleeding
Time frame: Hour 12
Delay for ablation of surgical drainage
Time frame: Day of ablation of surgical drainage, 24 hours
Antiemetic medication use
Time frame: end of intensive care unit stay, 24 hours
Delay to first extubation (number of hours)
Time frame: Hour of first extubation, an average of 5 hours
Intensive care unit stay (number oh days)
Time frame: Day of intensive care unit stay exit
Hospital stay (number of days)
Time frame: Day of hospital exit, an average of 7 days
Creatinine level variation
Time frame: Day 5
Creatinine level variation
Time frame: Day 28
Creatinine level variation
Time frame: Day 90
Renal replacement therapy use during intensive care stay
Time frame: end of intensive care unit stay, an average of 24 hours
Renal replacement therapy dependency
Time frame: Day 28
Renal replacement therapy dependency
Time frame: Day 90
Mortality of any cause
Time frame: During hospital stay, an average of 7 days
Mortality of any cause
Time frame: Day 28
Mortality of any cause
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2025.
- Results publication: PubMed 31138465Schweizer R, Lameche M, Coelembier C, Portran P, Fornier W, Colombet B, Grinberg D, Pozzi M, Jacquet-Lagreze M, Fellahi JL. Cardiopulmonary Bypass Priming with Hydroxyethyl Starch 6% 130/0.4 or Sodium Chloride 0.9%: A Preliminary Double-Blind Randomized Controlled Study in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Dec;33(12):3534-3535. doi: 10.1053/j.jvca.2019.05.003. Epub 2019 May 10. No abstract available.
Related trials for Extracorporeal Circulation
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Active, not recruitingObservational study
Coagulation Profiles in Conventional and Minimal Invasive Extracorporeal Circulation
Coagulation Changes During Coronary Artery Bypass Grafting
RecruitingObservational study
Observational Study of Platelet Dysfunction Assessed by Thromboelastography in Cardiovascular Surgery (DISPLATEG)
Blood Platelet Disorders, Cardiac Surgery
Enrolling by invitation
Optimizing Breathing and Blood Flow in Patients Treated With VA ECMO
VA-ECMO
RecruitingObservational study
Effects of Extracorporeal Circulation Techniques on Cerebral Perfusion in CABG Surgery
Intracranial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius) and Sodium Chloride 0.9% (Fresenius) in people with Extracorporeal Circulation and Cardiac Surgery, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Supplementary volume of fluid administered during cardiopulmonary bypass (ml) (time frame: Day 1 (From initiation to separation of cardiopulmonary bypass)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02906514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2025.